Medtronic plc received U.S. FDA approval for its Omniasecure defibrillation lead for placement in the right ventricle to treat arrhythmias. Medtronic said the lead is the smallest made at 4.7 French or 1.6 mm, making it suitable for individuals as young as age 12 and others with smaller anatomies, particularly women.
Boston Scientific Corp.’s Farapulse pulsed field ablation system racked up more than $1 billion in revenue in its first year; its Watchman left atrial appendage occluder holds more than 90% of the market. How does the company choose and position its products for such astonishing success?
Med-tech veterans advised companies looking to launch new products in fields with dominant players to mind their 'Ps and Qs,' but not the ones your mother drilled in childhood. Rather than good manners, they urged competitors attending Device Talks Minnesota to ensure they had the right people, product, proof, pace and quality control.
What does it take to create space in a market dominated by a single player? Three challengers to Johnson & Johnson's Shockwave shared their strategies for gaining traction in intravascular lithotripsy (IVL) at the Device Talks meeting June 11 in Minneapolis.
Omada Health Inc. rang the opening bell on the New York Stock Exchange on June 6, marking its first day as a public company, but it won’t be the most recent IPO for very long. Continuing the brisk pace seen so far this year, Caris Life Sciences Inc. is hot on its heels with a road show in progress leading up to its expected debut on the Nasdaq next week.
In the midst of June’s peak wedding season, Highridge Medical LLC called it splitsville – selling its bone healing division to Avista Healthcare Partners. The latest separation continues the sundering of what Zimmer Biomet Holdings Inc. so carefully joined together a decade ago.
Far from eliminating the need for weight-loss procedures, glucagon-like peptide-1 receptor agonists could drive more people to seek them out. At least that’s what Fractyl Health Inc. and Bariendo Inc. hope, and they have strong evidence to support their case with a recent meta-analysis showing that individuals discontinuing the popular weight loss medications regain all their weight and more within two years.
Vantive Health LLC, formerly the kidney care business of Baxter International Inc., plans to invest $1 billion over the next five years in development of digitally enabled dialysis products, innovation in acute organ support therapy options and expanding production capacity.
The U.S. FDA’s decision to grant breakthrough device designation for Bivacor Inc.’s titanium total artificial heart (TAH) sent real hearts aflutter at the Huntington, Calif.-based company’s headquarters. While the designation supports use of the TAH as a bridge to transplant for adults with biventricular or univentricular heart failure for whom current options are insufficient or unsuitable, Bivacor hopes its device will eventually serve as a long-term heart replacement.